FDA approves first over-the-counter at-home test for COVID-19, flu

The Food and Drug Administration (FDA) approved the first over-the-counter at-home test for both COVID-19 and the flu on Friday. 

The FDA said in a release that the test can differentiate between and detect Influenza A and B, which most commonly cause the flu in humans, and SARS-CoV-2, the virus that causes COVID-19. 

Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said in the release that the test is a “major milestone” to increase consumers’ access to tests that can be taken at home. 

“The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs,” he said. “We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them.” 

The all-in-one test, called the Lucira COVID-19 & Flu Test, is meant for people who have symptoms of a respiratory tract infection. People 14 years old and older will be allowed to collect the samples themselves, while an adult can collect the samples for testing for individuals as young as 2 years old. 

To use the test, a user will move a nasal swab with a sample in a test unit to learn in 30 minutes or less if they are positive for the flu or COVID-19. 

In a study, the test successfully detected 100 percent of negative and 88.3 percent of positive COVID-19 samples, 99.3 percent of negative and 90.1 percent of positive Influenza A samples and 99.9 percent of negative Influenza B samples.

Not enough cases of Influenza B are circulating to include in a study, and Lucira will continue to collect samples to determine how the test is able to detect it in real-world settings, the release said.

The company, however, is also facing financial difficulties, as it announced on Wednesday that it is filing for Chapter 11 bankruptcy and seeking to sell its business. Lucira said in its announcement that it had expected to receive emergency use authorization from the FDA in August, but the approval process took longer than expected and caused “high expenditures without new revenue.”

Lucira told The Hill in a statement that they “fully intend” to move forward with their normal operations while pursuing a sale of the company once their first-day bankruptcy motions are approved in court.

“We’re focused on delivering for our customers and partners, as we have in the past,” the statement reads.

CEO Erik Engelson said the company is “very excited” to receive the FDA’s emergency use authorization for the test.

“This is a major milestone for Lucira Health and for at-home diagnostics, and I can’t thank our employees and partners enough for seeing this through, and of course, for the FDA’s recognition,” Engelson added.

Officials and health experts warned of a particularly difficult flu season this year as many people were resuming normal activities during the winter for the first time since the COVID-19 pandemic began. 

The level of people reporting a fever along with a cough or sore throat reached what the Centers for Disease Control and Prevention considers “very high” throughout most of the country by November. But the rate has largely subsided in most states in recent weeks.

Reported COVID-19 levels have also stayed relatively low throughout the winter, but that is dependent on the amount of testing. COVID-19 hospitalizations rose somewhat starting in mid-November but have fallen since the start of January.